This two-part blog serves to summarize the Medical Device and Diagnostic Solution’s research on General Data Privacy Regulation (GDPR) compliance for medical device sponsors. It does not serve as legal advice; it is a summary of information gleaned by our Medical Device and Diagnostic Solutions through a review of the …
Are your CERs ready for MDR?
Do you understand the key changes for CERs? The interplay of MDR and MEDDEV is complex. The release of the revised guidance regarding Clinical Evaluations (MEDDEV 2.7/1 Rev. 4) in 2016 introduced some significant changes to the process of clinical evaluation. Now, even with the all but official postponement of …
How a no-deal Brexit might affect medical device development: legal consequences and risk mitigation strategies
How could a no-deal Brexit affect my medical device lifecycle? Considerable uncertainty surrounds Britain’s imminent exit from the EU, and it is possible that there could be a “no-deal Brexit” scenario. The full implications are still unclear, however it is a stressful time for UK manufacturers and sponsors of medical …